OBJECTIVE To work for a Pharmaceutical company or a Contract Research Organization (CRO), working in areas related to clinical field trials of new drugs, efficiently and effectively utilizing my skills, experience and knowledge, thereby contributing to the eradication of diseases in various therapeutic areas. I would like to work in a challenging work environment that facilitates the opportunity to grow.

HIGHLIGHTS • Masters Degree in Medical Microbiology.

STRENGTHS• Excellent verbal & written communication skills and work well independently or as part of a team. • Detail and multi-task oriented with strong organizational skills. • Good scientific background and knowledge of Immunology.

SUMMARY OF PROFESSIONAL EXPERIENCE • Total No. of Years Experience: 12+ yearsPROFESSIONAL EXPERIENCE – DETAILSPfizer September 2011 - September 2012Senior Medical Writer (contract) • Using appropriate templates and analyzing statistical tables and listings for preparing detailed clinical study reports for Phase 1 or 2 studies as per FDA formats as well as sFDA (China) formats.• Preparing interim clinical study reports as required for various studies.• Responsible for preparing pediatric web synopses for legacy Wyeth studies.• Knowledge of different global document management systems (GDMS; EDMS)• Working on multiple projects within defined timelines and across different teams.• Trained in client SOPs.

Freelance Contractor February 2008 - September 2011Senior Medical Writer • As Senior Medical Writer support different pharmaceutical clients and manage projects and project timelines and work with cross-functional teams.• Responsible for preparing detailed clinical study reports for Phase I-IV trials by analyzing and interpreting statistical tables and figures using company defined templates.• Responsible for preparing Integrated clinical summaries (ISS and ISE) or other modules of a CTD.• Also responsible for writing safety narratives based on defined templates.• Preparing and updating IND Annual Reports• Responsible for the development and update of Investigator Brochure's.• Working knowledge of document management systems (Documentum, eDMS)• Trained in client SOPs.

Eisai Medical Research Inc., New Jersey, USA February 2003 – September 2006Senior Medical Writer (June 2005 – September 2006)Medical Writer (February 2003 – June 2005)• Responsible for interpreting statistical tables and figures to prepare detailed clinical study reports for mainly the CNS therapeutic area and other therapeutic areas.• Responsible for the preparation of Clinical Protocols, using defined templates for the Sepsis, GI, CNS, Oncology and other therapeutic areas.• Responsible for development or update of Investigator Brochures (IBs).• Involved in the word processing required during the preparation of the different clinical documents.• Involved in the electronic Document Management System (eDMS) pilot study and authored/coordinated a Clinical Study Protocol and Clinical Study Report in eDMS.• Performed QC and peer review on the various clinical documents.• Interact with Study Directors, Regulatory and Biometrics (as needed) in the preparation of Clinical Study Reports, Protocols and IBs.• Mentoring other Medical Writers. • Clinical Data Management Centre India (CDMCI)